Expiration date: 03/2025
Structure and Composition:
1 tablet contains 200 mg of carbamazepine in blisters of 10 pcs., In a cardboard bundle 10 packages.
1 tablet retard coated liner - 200 and 400 mg contour bezgyachakova pack of 10, in a cardboard 3 bundle packaging.
Dosage:
INSTRUCTION for medical use of the drug ZEPTOL
Pharmacological Committee of the Russian Ministry of Health November 15, 2001, Minutes ? 16
The international non-proprietary name
Carbamazepine
chemical name
5-carbamoyl? 5H-dibenz 9 (beta, f) azepine.
dosage form
Retard tablets, coated tablets.
Composition
Carbamazepine - 0.2 and 0.4 g, and adjuvants.
Description
Tablets round biconvex brown, film-coated, scored on one side.
pharmacological properties
It refers to the group carbamazepine antiepileptics. Anticonvulsant activity of the drug is combined with antidepressant (timolepticheskoe) and mood stabilizer effects. The drug reduces the frequency and intensity of seizures and is characterized by a large therapeutic breadth, low toxicity and low side effects. It has analgesic effect of trigeminal neuralgia.
Indications
Applied for the treatment of epilepsy (large and small seizures, mixed forms of epilepsy, focal epilepsy, post-traumatic and local forms postentsefaliticheskogo origin) trigeminal neuralgia prevention faznoprotekayuschih affective disorder (manic-depressive psychosis and other psychotic mood disorders).
The drug is used strictly prescribed by a doctor to avoid complications.
Dosing and Administration
Inside, during or after delivery, squeezed small amounts of liquid. epilepsy treatment (if possible - as monotherapy) for adults, an initial dose of 0.2 g (1 tablet) 1-2 times a day. Further dose is gradually increased until the optimal current, which is typically 0.4 g (2 tablets) 2-4 times a day.
Babies average daily dose determined by the rate of 10-20 mg / kg body weight per day and amounts: 4-12 months - years 0.1-0.2 g 5.1 - 1 0.2-0.4 g -2 reception 5-10 years - 0.4-0.6 g 2-3 reception 10-15 years - 0.6-1 g in 3 divided doses.
Treatment trigeminal neuralgia initial dose is 0.2-0.4 g (1-2 tablets) per day, the dosage is gradually increased if necessary to 0.6-0.8 g in divided doses. After the disappearance of pain gradually reduce the dose to 0.2 grams per day.
Prevention of affective disorders in the first week of daily dose is 0.2-0.4 (two tablets). Subsequently increase the dose of 1 tablet per week, bringing it to about 1 g daily dose is divided evenly at 3-4 hours. Duration of treatment is determined individually.
Side effect
From the central and peripheral nervous system: often - dizziness, ataxia, drowsiness, headache, rarely - a violation of accommodation, diplopia, nystagmus, oculomotor disturbances, dysarthria, tinnitus, peripheral neuritis, paresthesia, muscle weakness, aggressive behavior, hallucinations, impaired consciousness , activation of psychosis.
From the digestive system: vomiting, nausea, dry mouth, rarely - increased activity of serum transaminases, jaundice, diarrhea, constipation, loss of appetite, abdominal pain, glossitis, stomatitis, hepatitis.
Since the cardiovascular system: rarely - conduction disturbances infarction, bradycardia, arrhythmia, heart failure, thrombosis, thromboembolism, collapse.
From hemopoiesis system: leucopenia, eosinophilia, thrombocytopenia, rarely - leukocytosis, anemia.
From the urinary system: rarely - renal dysfunction, renal failure.
In addition, the possible weight gain, edema, metabolic disorders, gynecomastia, thyroid dysfunction, pneumonia, skin rash, pruritus, arthralgia.
Interaction
Zeptol strengthens the liver microsomal enzyme activity and may reduce the effect of certain drugs metabolized in the liver (oral anitikoagulyantov et al.).
During treatment Zeptolom may decrease the reliability of the action of hormonal contraceptives.
Zeptol not appointed concurrently with MAO inhibitors and furazolidone.
Phenobarbital and hexamidine weaken the effect of the drug.
The concentration of carbamazepine in plasma while the application: increase - antibiotics, macrolide, isoniazid, calcium channel blockers, niacinamide, cimetidine, desipramine reduced - phenobarbital, phenytoin, primidone, valproic acid, theophylline.
Drug treatment incompatible with alcohol.
Contraindications
Hypersensitivity to carbamazepine and tricyclic antidepressants: AV-blockade, blood disease, expressed human liver, kidney, heart glaucoma, pregnancy (I term), breast-feeding.
Warnings
Drug treatment should be under medical supervision. Before treatment is necessary to conduct a study of liver function and blood picture. 1 time per month - in later during the first month of treatment should be carried out a study of the blood picture 1 time per week.
During treatment is not recommended to engage in activities that require high mental and physical reactions (driving, operating machinery complex).
Overdose
Symptoms: increased side effects of the drug.
Treatment: gastric lavage, the appointment of activated charcoal, if necessary - symptomatic therapy.
release Form
The tablets retard film-coated, 0.2 and 0.4 g per strip in a cardboard box - 3 strips.
Storage conditions
List B. In a dry, dark place, out of reach of children, at a temperature no higher than 30 ° C.
Shelf life
2 years. Do not use beyond the expiration date printed on the package.
Holiday from drugstores
By prescription.
Manufacturer
"Sun Pharmaceutical Industries Ltd" (India).
Dosage and administration:
Pills: Inside, adults and adolescents over 15 years old with epilepsy and neuralgia initial dose - 200 mg 1-2 times a day with a gradual increase in dose (100 mg at intervals of 1 week) until the optimal therapeutic - 600-1200 mg / day ( the maximum daily dose - 1.8 g). In manic-depressive psychosis, the initial dose - 400 mg / day, divided into 2 doses, with a gradual increase to 600 mg / day (maximum daily dose). Children up to 1 year (2 times a day) - 100-200 mg / day, 1-5 years - 200-400 mg / day, 5-10 years - 400-600 mg / day, 11-15 years - 600-1000 mg / day.
Retard tablets, film-coated, inside, during or after delivery, squeezed small amounts of liquid. In epilepsy: adult starting dose - 200 mg 1-2 times a day, then the dose is gradually increased until the optimal - 400 mg 2-4 times a day. Babies: calculation of 10-20 mg / kg, 4-12 months - 100-200 mg reception 1-2, 1-5 years - 200-400 mg 1-2 reception 5-10 years - 400-600 mg 2-3 hours, 10-15 years - 600-1000 mg in 3 divided doses.
Trigeminal neuralgia: an initial dose - 200-400 mg / day, then gradually increase the dose, if necessary, up to 600-800 mg in divided doses. After the disappearance of the pain gradually reduce the dose to 200 mg / day.
Prevention of affective disorders: the first week of daily dose - 200-400 mg, the daily dose in a subsequent increase (see Table 1 for a week.) To 1000 mg, and taking for 3-4 hours.
Duration of treatment is determined individually.
